Validation & compliance
Autonomy that lives inside your validated envelope.
Physical AI on a sterile line is only useful if it is qualifiable. Sterira is architected from the ground up for GMP, GAMP 5, 21 CFR Part 11, and EU GMP Annex 1, with bounded autonomy, documented control envelopes, and validation support at every step.
Design principles
Grounded, auditable, reversible.
Grounded
Every action traces to a specific signal and a specific rule, never an unexplained inference.
Auditable
A 21 CFR Part 11 trail records every action, alarm, and override with attribution.
Reversible
Autonomy is bounded to validated envelopes; actions are reviewable and can be rolled back.
Bounded autonomy
The agent can only act inside the box you validated.
Control envelopes are defined, qualified, and locked. The agent optimizes within them and cannot exceed them. Every setpoint change is checked against the envelope before it reaches a machine.
- Envelopes qualified once, enforced always.
- Out-of-envelope actions are blocked, not attempted.
- Autonomy level is configurable per workflow.
CSV lifecycle
GAMP 5 from URS to PQ.
- 01
Requirements
User and functional requirements captured with traceability from day one.
- 02
Risk assessment
GAMP 5 risk-based approach scopes the qualification effort to what matters.
- 03
IQ / OQ / PQ
Installation, operational, and performance qualification with reusable protocols.
- 04
Continued verification
Ongoing monitoring keeps the validated state through change control.
QbD & design space
Evidence regulators can read.
The digital twin maps the robust design space for each process, generating the quality-by-design evidence that supports filings and change control, so a faster cycle or tighter fill is documented, not improvised.
See the digital twin →Frameworks
What we map to.
Contamination Control Strategy
Live, holistic CCS evidence as the revised EU GMP Annex 1 expects.
Electronic records & signatures
Attributable, time-stamped, tamper-evident audit trail throughout.
Risk-based CSV
Computerized system validation scaled to risk, with reusable protocols.
QbD & lifecycle
Q8-Q10 quality-by-design and product lifecycle alignment.
Validation support
We bring the paperwork, not just the software.
Validation plan
A tailored VP and traceability matrix for your deployment scope.
Protocol templates
Pre-built IQ/OQ/PQ protocols you adapt, not author from scratch.
Risk assessments
GAMP 5 risk documentation aligned to your quality system.
Audit support
Inspection-ready packages and SME support during regulatory audits.
"The bounded-envelope design is what got this past our quality board. The agent literally cannot leave the qualified range, and every action is signed and traceable."
Sterile injectables manufacturer
FAQ
Common questions.
Yes, when it operates inside qualified control envelopes with a Part 11 trail and human oversight. That bounded, auditable design is exactly how Sterira is architected.
Yes. Validation plans, IQ/OQ/PQ protocol templates, risk assessments, and audit support tailored to your quality system.
Model and parameter changes flow through documented change control with design-space evidence from the twin, keeping the validated state intact.
Bring it to your quality board.
Request the validation pack and see the compliance architecture in full.